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TPLC
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Device
high intensity ultrasound system for prostate tissue ablation
Definition
Prostate tissue ablation
Product Code
PLP
Regulation Number
876.4340
Device Class
2
Premarket Reviews
Manufacturer
Decision
INSIGHTEC, INC
SUBSTANTIALLY EQUIVALENT
1
INSIGHTEC, LTD.
SUBSTANTIALLY EQUIVALENT
1
PROFOUND MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
PROFOUND MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
3
PROFOUND MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2021
1
1
2022
6
6
2023
6
6
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
15
15
Use of Device Problem
4
4
Insufficient Information
2
2
Device Handling Problem
2
2
Inadequate or Insufficient Training
2
2
Output above Specifications
1
1
Difficult to Insert
1
1
Electrical /Electronic Property Problem
1
1
Output Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fistula
15
15
No Clinical Signs, Symptoms or Conditions
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematuria
1
1
Perforation
1
1
Urethral Stenosis/Stricture
1
1
Diarrhea
1
1
Nerve Damage
1
1
Constipation
1
1
Fibrosis
1
1
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